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Published in: Langenbeck's Archives of Surgery 1/2021

01-02-2021 | Appendicitis | Original Article

Comparison of new versus reused Harmonic scalpel performance in laparoscopic appendectomy in patients with acute appendicitis—a randomized clinical trial

Authors: Jakov Mihanović, Nataša Lisica Šikić, Ivana Mrklić, Zvonimir Katušić, Robert Karlo, Miro Jukić, Ana Jerončić, Zenon Pogorelić

Published in: Langenbeck's Archives of Surgery | Issue 1/2021

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Abstract

Background

The aim of this study was to compare lateral thermal damage of the appendix and clinical outcomes after laparoscopic appendectomy using new versus reused Harmonic scalpels.

Methods

A total of 100 consecutive patients with acute appendicitis who underwent laparoscopic appendectomy were enrolled in the two-center, randomized clinical trial. Using a computer random number generator, patients were allocated to new or reused group. Histopathological measurement of lateral thermal damage of the appendiceal base and mesoappendix, speed of transection of the appendiceal base, duration of surgery, subjective rating of device functionality, length of hospital stay, and complications were compared within groups.

Results

The median lateral thermal damage on the appendiceal base in the new group (N = 49) was 0.2 mm (IQR 0.1–0.2) and 0.1 mm (IQR 0.1–0.3) in the reused group (N = 51) (P = 0.644), while on the mesoappendix for both groups, thermal damage was 0.1 mm (IQR 0.1–0.2) (P = 0.418). The median time required for base transection in both groups was 8 s (IQR 7–9) (P = 0.776). The median duration of surgery was also comparable between the groups (22 min, IQR 20–30 vs 25 min, IQR 21–35; P = 0.233). Two postoperative complications in the new group and one in the reused group were recorded (4% vs 2%; P = 0.536). Surgeons’ subjective assessment of the instrument did not reveal significant difference between the groups in all of the investigated categories.

Conclusions

The results of our study support the reuse of Harmonic scalpels especially in the settings where economic constraints might hamper access to minimally invasive surgery to a larger number of patients. The results obtained on laparoscopic appendectomy might not be reproducible to other more demanding surgical procedures.

Trial registration

ClinicalTrials.​gov registry under identifier NCT04226482
Literature
1.
go back to reference GlobalSurg Collaborative (2018) Laparoscopy in management of appendicitis in high-, middle-, and low-income countries: a multicenter, prospective, cohort study. Surg Endosc 32:3450–3466CrossRef GlobalSurg Collaborative (2018) Laparoscopy in management of appendicitis in high-, middle-, and low-income countries: a multicenter, prospective, cohort study. Surg Endosc 32:3450–3466CrossRef
2.
go back to reference Siu J, Hill AG, MacCormick AD (2017) Systematic review of reusable versus disposable laparoscopic instruments: costs and safety. ANZ J Surg 87:28–33CrossRef Siu J, Hill AG, MacCormick AD (2017) Systematic review of reusable versus disposable laparoscopic instruments: costs and safety. ANZ J Surg 87:28–33CrossRef
3.
go back to reference Koh A, Kawahara K (2005) Current practices and problems in the reuse of single-use devices in Japan. J Med Dent Sci 52:81–89PubMed Koh A, Kawahara K (2005) Current practices and problems in the reuse of single-use devices in Japan. J Med Dent Sci 52:81–89PubMed
4.
go back to reference Popp W, Rasslan O, Unahalekhaka A, Brenner P, Fischnaller E, Fathy M, Goldman C, Gillespie E (2010) What is the use? An international look at reuse of single-use medical devices. Int J Hyg Environ Health 213:302–307CrossRef Popp W, Rasslan O, Unahalekhaka A, Brenner P, Fischnaller E, Fathy M, Goldman C, Gillespie E (2010) What is the use? An international look at reuse of single-use medical devices. Int J Hyg Environ Health 213:302–307CrossRef
5.
go back to reference Hussain M, Balsara KP, Nagral S (2012) Reuse of single-use devices: looking back, looking forward. Natl Med J India 25:151–155PubMed Hussain M, Balsara KP, Nagral S (2012) Reuse of single-use devices: looking back, looking forward. Natl Med J India 25:151–155PubMed
6.
go back to reference Garay OU, Ezequiel GE, Rodríguez V, Spira C, Augustovski F, Pichon-Riviere A (2017) Single-use devices in Argentina: cost comparison analysis of a “re-use” versus a “single-use” policy for trocars, endocutters, linear cutters, and Harmonic scalpels. Value Health Reg Issues 14:89–95CrossRef Garay OU, Ezequiel GE, Rodríguez V, Spira C, Augustovski F, Pichon-Riviere A (2017) Single-use devices in Argentina: cost comparison analysis of a “re-use” versus a “single-use” policy for trocars, endocutters, linear cutters, and Harmonic scalpels. Value Health Reg Issues 14:89–95CrossRef
7.
go back to reference Wang D, Wu J (2019) Reprocessing and reuse of single-use medical devices in China: a pilot survey. BMC Public Health 19:461CrossRef Wang D, Wu J (2019) Reprocessing and reuse of single-use medical devices in China: a pilot survey. BMC Public Health 19:461CrossRef
8.
go back to reference Jacobs P, Polisena J, Hailey D, Lafferty S (2008) Economic analysis of reprocessing single-use medical devices: a systematic literature review. Infect Control Hosp Epidemiol 29:297–301CrossRef Jacobs P, Polisena J, Hailey D, Lafferty S (2008) Economic analysis of reprocessing single-use medical devices: a systematic literature review. Infect Control Hosp Epidemiol 29:297–301CrossRef
9.
10.
go back to reference Collier R (2011) Reprocessing single-use devices: an international perspective. CMAJ 183:1244CrossRef Collier R (2011) Reprocessing single-use devices: an international perspective. CMAJ 183:1244CrossRef
11.
go back to reference Kwakye G, Brat GA, Makary MA (2011) Green surgical practices for health care. Arch Surg 146:131–136CrossRef Kwakye G, Brat GA, Makary MA (2011) Green surgical practices for health care. Arch Surg 146:131–136CrossRef
12.
go back to reference Renton D, Denk P, Varban O (2018) Reprocessed single-use devices in laparoscopy: assessment of cost, environmental impact, and patient safety. Surg Endosc 32:4310–4313CrossRef Renton D, Denk P, Varban O (2018) Reprocessed single-use devices in laparoscopy: assessment of cost, environmental impact, and patient safety. Surg Endosc 32:4310–4313CrossRef
13.
go back to reference Grantcharov P, Ahmed S, Wac K, Rivas H (2019) Reprocessing and reuse of single-use medical devices: perceptions and concerns of relevant stakeholders toward current practices. Int J Evid Based Healthc 17:53–57CrossRef Grantcharov P, Ahmed S, Wac K, Rivas H (2019) Reprocessing and reuse of single-use medical devices: perceptions and concerns of relevant stakeholders toward current practices. Int J Evid Based Healthc 17:53–57CrossRef
15.
go back to reference Brady JT, Bhakta A, Steele SR, Trunzo JA, Senagore AJ, Holmgren K, Schillero A, Champagne BJ (2017) Reprocessed bipolar energy for laparoscopic colectomy: is it worth it? Am J Surg 214:59–62CrossRef Brady JT, Bhakta A, Steele SR, Trunzo JA, Senagore AJ, Holmgren K, Schillero A, Champagne BJ (2017) Reprocessed bipolar energy for laparoscopic colectomy: is it worth it? Am J Surg 214:59–62CrossRef
16.
go back to reference de Sousa MB, Queiroz e Melo J, Logarinho Monteiro J, Rente G, Teixeira Bastos P (2018) Reprocessing of single-use medical devices: clinical and financial results. Port J Public Health 36:150–156CrossRef de Sousa MB, Queiroz e Melo J, Logarinho Monteiro J, Rente G, Teixeira Bastos P (2018) Reprocessing of single-use medical devices: clinical and financial results. Port J Public Health 36:150–156CrossRef
17.
go back to reference Gundogdu H, Ocal K, Caglikulekci M, Karabiber N, Bayramoglu E, Karahan M (1998) High-level disinfection with 2% alkalinized glutaraldehyde solution for reuse of laparoscopic disposable plastic trocars. J Laparoendosc Adv Surg Tech A 8:47–52CrossRef Gundogdu H, Ocal K, Caglikulekci M, Karabiber N, Bayramoglu E, Karahan M (1998) High-level disinfection with 2% alkalinized glutaraldehyde solution for reuse of laparoscopic disposable plastic trocars. J Laparoendosc Adv Surg Tech A 8:47–52CrossRef
18.
go back to reference Colak T, Ersoz G, Akca T, Kanik A, Aydin S (2004) Efficacy and safety of reuse of disposable laparoscopic instruments in laparoscopic cholecystectomy: a prospective randomized study. Surg Endosc 18:727–731CrossRef Colak T, Ersoz G, Akca T, Kanik A, Aydin S (2004) Efficacy and safety of reuse of disposable laparoscopic instruments in laparoscopic cholecystectomy: a prospective randomized study. Surg Endosc 18:727–731CrossRef
19.
go back to reference Gärtner D, Münz K, Hückelheim E, Hesse U (2008) Ultrasound scissors: new single-use instruments vs. resterilised single-use instruments - a prospective randomised study. GMS Krankenhhyg Interdiszip 3:Doc20PubMedPubMedCentral Gärtner D, Münz K, Hückelheim E, Hesse U (2008) Ultrasound scissors: new single-use instruments vs. resterilised single-use instruments - a prospective randomised study. GMS Krankenhhyg Interdiszip 3:Doc20PubMedPubMedCentral
20.
go back to reference Perko Z, Pogorelić Z, Bilan K, Tomić S, Vilović K, Krnić D, Druzijanić N, Kraljević D, Juricić J (2006) Lateral thermal damage to rat abdominal wall after harmonic scalpel application. Surg Endosc 20:322–324CrossRef Perko Z, Pogorelić Z, Bilan K, Tomić S, Vilović K, Krnić D, Druzijanić N, Kraljević D, Juricić J (2006) Lateral thermal damage to rat abdominal wall after harmonic scalpel application. Surg Endosc 20:322–324CrossRef
21.
go back to reference Pogorelić Z, Perko Z, Druzijanić N, Tomić S, Mrklić I (2009) How to prevent lateral thermal damage to tissue using the harmonic scalpel: experimental study on pig small intestine and abdominal wall. Eur Surg Res 43:235–240CrossRef Pogorelić Z, Perko Z, Druzijanić N, Tomić S, Mrklić I (2009) How to prevent lateral thermal damage to tissue using the harmonic scalpel: experimental study on pig small intestine and abdominal wall. Eur Surg Res 43:235–240CrossRef
22.
go back to reference Pogorelić Z, Katić J, Mrklić I, Jerončić A, Šušnjar T, Jukić M, Vilović K, Perko Z (2017) Lateral thermal damage of mesoappendix and appendiceal base during laparoscopic appendectomy in children: comparison of the harmonic scalpel (Ultracision), bipolar coagulation (LigaSure), and thermal fusion technology (MiSeal). J Surg Res 212:101–107CrossRef Pogorelić Z, Katić J, Mrklić I, Jerončić A, Šušnjar T, Jukić M, Vilović K, Perko Z (2017) Lateral thermal damage of mesoappendix and appendiceal base during laparoscopic appendectomy in children: comparison of the harmonic scalpel (Ultracision), bipolar coagulation (LigaSure), and thermal fusion technology (MiSeal). J Surg Res 212:101–107CrossRef
23.
go back to reference Andersson M, Andersson RE (2008) The appendicitis inflammatory response score: a tool for the diagnosis of acute appendicitis that outperforms the Alvarado score. World J Surg 32:1843–1849CrossRef Andersson M, Andersson RE (2008) The appendicitis inflammatory response score: a tool for the diagnosis of acute appendicitis that outperforms the Alvarado score. World J Surg 32:1843–1849CrossRef
24.
go back to reference Pogorelic Z, Buljubasic M, Susnjar T, Jukic M, Pericic TP, Juric I (2019) Comparison of open and laparoscopic appendectomy in children: a 5-year single center experience. Indian Pediatr 56:299–303CrossRef Pogorelic Z, Buljubasic M, Susnjar T, Jukic M, Pericic TP, Juric I (2019) Comparison of open and laparoscopic appendectomy in children: a 5-year single center experience. Indian Pediatr 56:299–303CrossRef
25.
go back to reference Dindo D, Demartines N, Clavien PA (2004) Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 240:205–213CrossRef Dindo D, Demartines N, Clavien PA (2004) Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 240:205–213CrossRef
26.
go back to reference Ha A, Richards C, Criman E, Piaggione J, Yheulon C, Lim R (2018) The safe use of surgical energy devices by surgeons may be overestimated. Surg Endosc 32:3861–3867CrossRef Ha A, Richards C, Criman E, Piaggione J, Yheulon C, Lim R (2018) The safe use of surgical energy devices by surgeons may be overestimated. Surg Endosc 32:3861–3867CrossRef
27.
go back to reference Družijanić N, Pogorelić Z, Perko Z, Mrklić I, Tomić S (2012) Comparison of lateral thermal damage of the human peritoneum using monopolar diathermy, Harmonic scalpel and LigaSure. Can J Surg 55:317–321CrossRef Družijanić N, Pogorelić Z, Perko Z, Mrklić I, Tomić S (2012) Comparison of lateral thermal damage of the human peritoneum using monopolar diathermy, Harmonic scalpel and LigaSure. Can J Surg 55:317–321CrossRef
28.
go back to reference ACOG Committee Opinion No. 769 (2019) Reprocessed single-use devices. Obstet Gynecol 133:e235–e237CrossRef ACOG Committee Opinion No. 769 (2019) Reprocessed single-use devices. Obstet Gynecol 133:e235–e237CrossRef
29.
go back to reference Brown SA, Merritt K, Woods TO, McNamee SG, Hitchins VM (2002) Effects of different disinfection and sterilization methods on tensile strength of materials used for single-use devices. Biomed Instrum Technol 36:23–27CrossRef Brown SA, Merritt K, Woods TO, McNamee SG, Hitchins VM (2002) Effects of different disinfection and sterilization methods on tensile strength of materials used for single-use devices. Biomed Instrum Technol 36:23–27CrossRef
30.
go back to reference Lopes Cde L, Graziano KU, Pinto Tde J (2011) Evaluation of single-use reprocessed laparoscopic instrument sterilization. Rev Lat Am Enfermagem 19:370–377CrossRef Lopes Cde L, Graziano KU, Pinto Tde J (2011) Evaluation of single-use reprocessed laparoscopic instrument sterilization. Rev Lat Am Enfermagem 19:370–377CrossRef
31.
go back to reference Zilberstein B, Silva RC, Valim SG, Yukui KT, Valentim R (2013) High-resolution tweezers for cutting and coagulation reprocessing. Arq Bras Cir Dig 26:230–233CrossRef Zilberstein B, Silva RC, Valim SG, Yukui KT, Valentim R (2013) High-resolution tweezers for cutting and coagulation reprocessing. Arq Bras Cir Dig 26:230–233CrossRef
35.
go back to reference Loftus TJ (2015) A comparison of the failure rate between original equipment manufacturer and reprocessed single-use energy devices. J Med Devices 9:044501CrossRef Loftus TJ (2015) A comparison of the failure rate between original equipment manufacturer and reprocessed single-use energy devices. J Med Devices 9:044501CrossRef
36.
go back to reference Weld KJ, Dryer S, Hruby G, Ames CD, Venkatesh R, Matthews BD, Landman J (2006) Comparison of mechanical and in vivo performance of new and reprocessed harmonic scalpels. Urology 67:898–903CrossRef Weld KJ, Dryer S, Hruby G, Ames CD, Venkatesh R, Matthews BD, Landman J (2006) Comparison of mechanical and in vivo performance of new and reprocessed harmonic scalpels. Urology 67:898–903CrossRef
37.
go back to reference Lester BR, Miller K, Boers A, Harris DC, Gamble WG (2010) Comparison of in vivo clinical performance and shaft temperature and in vitro tissue temperature and transection times between new and reprocessed harmonic scalpels. Surg Laparosc Endosc Percutan Tech 20:e150–e159CrossRef Lester BR, Miller K, Boers A, Harris DC, Gamble WG (2010) Comparison of in vivo clinical performance and shaft temperature and in vitro tissue temperature and transection times between new and reprocessed harmonic scalpels. Surg Laparosc Endosc Percutan Tech 20:e150–e159CrossRef
38.
go back to reference Stewart I (1997) “Single use only” labelling of medical devices: always essential or sometimes spurious? Med J Aust 167:538–539CrossRef Stewart I (1997) “Single use only” labelling of medical devices: always essential or sometimes spurious? Med J Aust 167:538–539CrossRef
39.
go back to reference Whitby RM, Looke DF (1997) “Single use only”: obfuscation or the necessary attainment of zero risk? Med J Aust 167:519–520CrossRef Whitby RM, Looke DF (1997) “Single use only”: obfuscation or the necessary attainment of zero risk? Med J Aust 167:519–520CrossRef
40.
go back to reference Jacobs P, Akpinar I (2018) Single-use medical devices: economic issues. Heart Asia 10:e011034CrossRef Jacobs P, Akpinar I (2018) Single-use medical devices: economic issues. Heart Asia 10:e011034CrossRef
42.
go back to reference Krüger CM (2008) Processing single-use medical devices for use in surgery - importance, status quo and potential. GMS Krankenhhyg Interdiszip 3:Doc21PubMedPubMedCentral Krüger CM (2008) Processing single-use medical devices for use in surgery - importance, status quo and potential. GMS Krankenhhyg Interdiszip 3:Doc21PubMedPubMedCentral
43.
go back to reference Probst P, Grummich K, Heger P, Zaschke S, Knebel P, Ulrich A, Büchler MW, Diener MK (2016) Blinding in randomized controlled trials in general and abdominal surgery: protocol for a systematic review and empirical study. Syst Rev 5:48CrossRef Probst P, Grummich K, Heger P, Zaschke S, Knebel P, Ulrich A, Büchler MW, Diener MK (2016) Blinding in randomized controlled trials in general and abdominal surgery: protocol for a systematic review and empirical study. Syst Rev 5:48CrossRef
Metadata
Title
Comparison of new versus reused Harmonic scalpel performance in laparoscopic appendectomy in patients with acute appendicitis—a randomized clinical trial
Authors
Jakov Mihanović
Nataša Lisica Šikić
Ivana Mrklić
Zvonimir Katušić
Robert Karlo
Miro Jukić
Ana Jerončić
Zenon Pogorelić
Publication date
01-02-2021
Publisher
Springer Berlin Heidelberg
Published in
Langenbeck's Archives of Surgery / Issue 1/2021
Print ISSN: 1435-2443
Electronic ISSN: 1435-2451
DOI
https://doi.org/10.1007/s00423-020-02039-y

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